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NCT Number: NCT05375643

SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)

SURGE aims to increase equity in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.

Recruiting

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

Supporting UnderRepresented populations in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (age 18 years or older)
  • Black, Latinx, OR older adult (age 70 years or older)
  • Scheduled for a new patient consultation
  • Suspected or confirmed advanced malignancy (requiring active treatment)
  • Gastrointestinal, hematologic, or thoracic cancer
  • DFCI patient at Longwood/Chestnut Hill, DFCI satellite at St. Elizabeth's Medical Center, or DFCI satellite at Merrimack Valley

Exclusion criteria

  • Malignancy or former malignancy that requires only surveillance
  • Not continuing care at a participating DFCI site
  • Speaks a language other than English or Spanish
  • Unable to provide consent

Treatment and study plan

SURGE

Behavioral

Video with or without person to person guidance to support decision making around genetic testing

Primary outcomes

  1. Genomic testing uptake

    Time frame: Up to 90 days of enrollment

    Intervention impact on rate of uptake of genomic testing

Secondary outcomes

  1. Patient interaction with the intervention

    Time frame: Up to 30 days of enrollment

    Interaction with each component of the intervention (as appropriate by intervention arm)

  2. Acceptability of questionnaire modality

    Time frame: Up to 30 days of enrollment

    We will use the System Usability Scale to measure usability of the questionnaire electronic tool. The 10-item System Usability Scale is scored on a five-point Likert scale, with 1 being Strongly Disagree and 5 being Strongly Agree.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadine J McCleary, MD MPH

CONTACT

[email protected]

(617) 632-6729

Nadine J McCleary, MD MPH

CONTACT

(617) 632-6729

Sponsors and collaborators

Lead sponsor

Nadine McCleary, MD, MPH

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 16, 2022
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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